NCT06601127

Study of Tiprogrel in the Treatment of High-risk Patients with Acute Ischemic Cerebrovascular Events (THRIVE).

A Phase 2, Randomised, Double-blind, Positive-controlled, Multicentre Study of Tiprogrel in the Treatment of Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Tianjin Institute of Pharmaceutical Research Co., Ltd · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.

Detailed description

To evaluate the safety and efficacy of Tiprogrel at different doses within 24 hours after symptom onset in Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack. Patients wil be enrolled and randomized to Low-dose Tiprogrel, High-dose Tiprogrel and Clopidogrel group in a 1:1:1 ratio. Patients in Low-dose Tiprogrel group and High-dose Tiprogrel group will accept long term dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 90 days) . Patients in Clopidogrel group will accept dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 21 days followed by Clopidogrel on days 22 to 90) . The primary endpoint is Percent of participants with ischemic stroke on the 90th day after treatment.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tiprogrel	Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
DRUG	Tiprogrel	Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
DRUG	Clopidogrel	Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.

Timeline

• Start date: 2025-02-21
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2024-09-19
• Last updated: 2025-03-07

Locations

2 sites across 1 country: China